A clear path for the innovative development of customized medical devices

Recently,The National Medical Products Administration and the National Health Commission jointly issued the "Regulations on the Supervision and Administration of Customized Medical Devices (Trial)"((Trial))》(hereinafter referred to as the "Regulations"),Since2020year1month1day, it has officially come into effect. As the first regulation to unify the supervision of customized medical devices,,the "Regulations" clearly stipulates the filing management, design and processing, usage management, and supervision and administration of customized medical devices. Industry experts believe that,the introduction of the "Regulations" will enable the standardized clinical use of customized medical devices,and is conducive to ensuring patient safety.

I. Meeting Clinical Needs

So-called customized medical devices,refer to personalized medical devices designed and produced by medical device manufacturers based on the special clinical needs of medical institutions to meet the rare and special lesion conditions of a designated patient,when existing products on the market in China cannot meet clinical needs,,由医疗器械生产企业基于医疗机构特殊临床需求而设计和生产,intended to improve the effectiveness of diagnosis and treatment for a designated patient.

According to Liu Zhongjun, chief physician of the Orthopedics Department of Peking University Third Hospital,,the introduction of the "Regulations" is directly related to actual clinical needs. For example,,after the resection of some lesions,,the wound surface has a special shape and size,,and standard medical devices cannot match it. Without customized medical devices,,some special treatment needs in clinical practice cannot be met.

Hao Yongqiang, chief physician of the Orthopedics Department of the Ninth People's Hospital affiliated with Shanghai Jiao Tong University School of Medicine, said that,with the rapid economic development of China,and the improvement of public health awareness,,individual differences among patients are increasingly valued,,and the clinical demand for customized medical devices is increasing. Currently,,many medical institutions in China have cooperated with medical device manufacturers and universities to carry out research and application of customized medical devices in orthopedics, craniomaxillofacial surgery, plastic surgery, oral restoration, and ophthalmology.

It is understood that,previously, due to the lack of relevant regulations in China,,most customized medical devices needed clinically were developed by medical institutions under the name of clinical research,after obtaining approval from the ethics committee,in cooperation with qualified medical device manufacturers.

Liu Zhongjun believes that,customized medical devices are closely related to innovation,,and the lack of legal basis will lead to a lack of supervision. Obviously,,the introduction of the "Regulations" provides a strong guarantee for regulating the production and use of customized medical devices,and better meeting clinical needs.

II. Strengthening Scientific Supervision

"The "Regulations" uses the qualifications and capabilities of enterprises and medical institutions as the main filing conditions,,is process-oriented in supervision,,relies on information disclosure and credit supervision,,is pragmatic,,and fully embodies'patient-centric,and clinically needs-oriented'supervisory concepts,,is innovative and groundbreaking in its supervisory approach,,and has found the best balance between ensuring safety, encouraging innovation, and meeting patient needs."Huang Yiwu, deputy director of the Medical Device Supervision Office of the Shanghai Municipal Drug Regulatory Bureau, commented on the "Regulations" in this way.

In Huang Yiwu's view,,implementing filing management for customized medical devices is a major highlight of the "Regulations"."Customized medical devices are only used for specific patients,,there is not enough population sample for clinical evaluation,,and it is difficult to register through the current registration management model. Therefore,,the drug regulatory authorities are pragmatic,and implement filing management for them,,while also leaving an interface for subsequent registration."Huang Yiwu said.

The "Regulations" clearly states that,when the number of clinical cases of customized medical devices and preliminary research meet the requirements for pre-market approval,,registration or filing should be applied for in accordance with the "Regulations on the Administration of Medical Device Registration" and the "Regulations on the Administration of In Vitro Diagnostic Reagent Registration".,Clinical usage data that complies with ethical guidelines and is true, accurate, complete, and traceable,can be used as clinical evaluation data for registration applications. The "Regulations" also requires that,medical device manufacturers and medical institutions jointly serve as filers for customized medical devices,,clarifying the responsibilities of medical institutions and manufacturers.

"Filing does not mean no management,,but rather strengthens mid- and post-event supervision by setting the qualifications, capabilities, and credit conditions of enterprises and medical institutions.,加强事中事后监管。"Huang Yiwu said.

Liu Zhongjun frankly stated that,to ensure patient safety,Not all medical institutions can use customized medical devices. The "Regulations" clearly stipulate the qualifications of enterprises and medical institutions that produce and use customized medical devices.,And it requires that customized medical devices shall not be entrusted for production.

To ensure product quality,Strengthen post-market supervision,The "Regulations" also require that the instructions and labels of customized medical devices can be traced back to specific patients.;The registrant shall report to the provincial(district, and city)drug regulatory departments and health and health administrative departments on the production and use of customized medical devices in the previous year.

III. Urgent need for exploration and practice

Although the promulgation of the "Regulations" provides institutional guarantees for the standardized production and use of customized medical devices,,but for customized medical devices to truly meet clinical needs,,further exploration and practice are needed.

First,The supervision of customized medical devices places higher demands on the capabilities of drug inspectors. The "Regulations" clearly state that,the production and use of customized medical devices are filed with the drug regulatory departments of the place where the medical device production enterprise is located,(and for imported products, the place where the agent is located.)Province(district, and city)The judgment standards for specific cases may vary among regulatory departments in different places.,Whether the reasons for customization are sufficient, whether the design scheme is scientific, whether the enterprise has the ability to produce it,,and even whether there is a""customized for customization""phenomenon, etc.,All need objective evaluation standards."This requires the State Drug Administration to increase training for regulatory personnel."An insider pointed out.

In addition,,medical-engineering interaction is the key and difficulty in the design and processing of customized medical devices. The "Regulations" clearly stipulate that,on the premise of protecting patient privacy,,manufacturing enterprises should extend the product design of customized medical devices to medical institutions."The production of customized medical devices requires long-term cooperation between engineers and doctors.,Otherwise,,the so-called customized medical devices produced may be far from the doctor's expectations."Hao Yongqiang emphasized.

The reporter also learned that,customized medical devices have high requirements for research and development and production processes,,but their clinical use has not yet been included in the medical institution's fee schedule.,Most medical device manufacturers are not very interested in this,,so how to improve the enthusiasm of manufacturers,still needs the support of relevant supporting policies.